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Sharon Cheng, of Save Our Surgery (SOS), which campaigned for surgery to be resumed at Leeds, said:

Sir Roger Boyle's comments of this morning are extremely unhelpful and undermine the progress made over the last few days to begin to rebuild heart patients' families' trust and confidence in the Leeds children's heart surgery unit.

His implication that surgery should not have been resumed at Leeds contradicts everything we have heard from NHS England, the Care Quality Commission and NHS medical director, Sir Bruce Keogh, who have all stated unequivocally that the unit is safe, hence their resumption of surgery.

Sir Bruce himself went on record this week saying he would feel comfortable having his child operated on in the unit.

Let me be absolutely clear - the Leeds unit would not be operating if there were any concerns whatsoever about mortality rates or anything else.

Once again, this is an example of Sir Roger Boyle speaking out without due regard to the necessary process, the verified facts or the implications of his actions on patients and their families.

He is not an impartial party in regards to Leeds and as an adviser to the Safe and Sustainable review, we do question his motives.

Leeds Teaching Hospitals NHS Trust has defended the re-opening of a children's heart unit after Sir Roger Boyle the Department of Health's former National Director for Heart Disease said he would not send his daughter to the unit.

On Monday we announced that we were reopening the children's heart unit at Leeds General Infirmary.

All partners were fully in agreement that this was the correct course of action to take and surgery has now resumed.

This was publicly reconfirmed at a meeting of councillors held in Leeds on Wednesday when the deputy medical director of NHS England reaffirmed the view that all the child heart surgery units in England, including Leeds, are safe to undertake surgery.

Anne Keatley-Clarke, chief executive of the Children's Heart Federation, has said that families affected by the suspension of the children's heart unit at Leeds General Infirmary are "very worried".

A lot of families have not yet been contacted and there are a lot families that are very worried there about what is going to happen with their children.

We are certainly receiving calls from parents, where they are extremely worried, and indeed at the moment extremely frightened by speaking out.

They are frightened of what might happen, there have certainly been all sorts of threats and we have been advising some of those parents to share the threats with the police, that's up to them if they want to take that forward.

Roger Boyle, director of the National Institute for Cardiovascular Outcomes Research (NICOR), has told Radio 4's Today programme that the decision to restart the children's heart unit at Leeds General Infirmary needs to be investigated.

I find it extraordinary that the medical director of the NHS still hasn't made a proper statement, still hasn't explained his actions and the actions of NHS England and that suggests to me that they are still scrabbling around trying to justify it.

We now need an investigation so we can get to the bottom of this decision, why it was taken, and we then need to understand that.